NCT06638853

Brief Summary

Research suggests that an individual's perceived ability to withstand distressing or upsetting emotions (i.e., distress tolerance; DT) is a common risk factor across several mental health conditions that commonly emerge during adolescence. This study aims to evaluate the acceptability, feasibility, and initial efficacy of a classroom-based DT skills training program for middle school students. This study will also explore associations between changes in DT and internalizing symptoms (e.g., anxiety, depression).

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

October 25, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 24, 2025

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

October 9, 2024

Last Update Submit

March 19, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Feasibility

    Consent rates during enrollment and attrition rates during the study will be used to assess the feasibility of the intervention.

    Pre-intervention and immediately post-intervention

  • Acceptability

    The investigators will use a brief feedback survey at the end of the study to gather information about participants' experiences of the intervention. Responses on this survey will be used to determine the acceptability of the intervention.

    Immediately post-intervention

  • Distress Tolerance

    The investigators will assess change in distress tolerance from pre-intervention to post-intervention. Distress tolerance will be indexed by total scores on the Distress Tolerance Scale (DTS), which is a 15-item self-report measure that assesses the respondent's perceived ability to withstand distressing or upsetting emotional states. Possible total scores can range from 15 to 75. Higher scores indicate higher distress tolerance. This outcome measure will be examined and compared for both the intervention group and the control group.

    Pre-intervention, immediately post-intervention, 3-month follow-up, and 6-month follow-up

Secondary Outcomes (1)

  • Internalizing Symptoms

    Pre-intervention, immediately post-intervention, 3-month follow-up, and 6-month follow-up

Study Arms (2)

Distress Tolerance Skills Training

EXPERIMENTAL

Students will participate in a series of classroom-based lessons aimed at increasing distress tolerance.

Behavioral: Distress Tolerance Skills Training

Standard Curriculum (Control)

NO INTERVENTION

Students will not participate in the distress tolerance skills training. They will receive only their standard curriculum during class time.

Interventions

These lessons are adapted from "DBT Skills in Schools: Skills Training for Emotional Problem Solving for Adolescents (DBT STEPS-A)" by Mazza et al. and include elements of mindfulness training, psychoeducation about emotions, and techniques/skills for managing extreme emotions.

Distress Tolerance Skills Training

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Middle school aged-youth attending Valley Catholic Middle School in grade 6, 7, or 8

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valley Catholic Middle School

Beaverton, Oregon, 97078, United States

Location

Study Officials

  • Bonnie Nagel, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 15, 2024

Study Start

October 25, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

March 24, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations